510k
Database
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Anesthesiology
550
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1722
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385
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1380
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252
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985
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2224
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2089
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127
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101
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474
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442
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283
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3050
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52
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515
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2498
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155
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Polymer Patient Examination Glove
416
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System, Image Processing,...
401
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Powered Laser Surgical Instrument
363
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Mask, Surgical
359
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Electrosurgical, Cutting &...
310
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System, Imaging, Pulsed Doppler,...
304
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Plate, Fixation, Bone
297
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Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
236
MAX
Intervertebral Fusion Device...
233
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Medex
Medical Device Manufacturer
·
FR , Saint-Priest
Medex - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2022
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Medex
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 29, 2025
Qitexio® 4-Way Stopcock (QIT014)
K242255
·
FMG
General Hospital
·
272d
Cleared
Mar 14, 2022
Qitexio
K203738
·
FMF
General Hospital
·
447d
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2
General Hospital
2